a study to test the pharmacodynamic, pharmacokinetic, safety, and tolerability of padsevonil in healthy study participants receiving either ethanol or cannabidiol

Conditions: Healthy Participants

Summary: the purpose of the study is to evaluate the pharmacodynamic (pd) interaction between steady-steady treatment with padsevonil (psl) and ethanol and the pharmacokinetic (pk) interaction between stead-state treatment with psl and cannabidiol (cbd).


Eligibility criteria:
inclusion criteria: * participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent * participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring * participant must have previous experience with alcohol consumption and, therefore, must be familiar with the effects and able to tolerate social amounts of alcohol * participant has a body weight of at least 50 kg (males) or 45 kg (females) and body mass index (bmi) within the range 18 to 30 kg/m2 (inclusive) * participants are male or female: * a male participant must agree to use contraception as detailed in the protocol during the treatment period and for at least 7 days after the last dose of study treatment and refrain from donating sperm during this period * a female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: * not a woman of childbearing potential (wocbp) as defined n the protocol or * a wocbp who agrees to follow the contraceptive guidance in the protocol during the treatment period and for at least 90 days after the last dose of study treatment exclusion criteria: * participant has history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data * participant has a history of chronic alcohol or drug abuse within the previous 6 months or the presence of drug or alcohol dependency at screening or day -1 or tests positive for alcohol and/or drugs at screening or day -1 * participant has a known hypersensitivity to any components of the study medication or comparative drugs (and/or an investigational device) as stated in this protocol * participant has a history of unexplained syncope or a family history of sudden death due to long qt syndrome * participant has lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years * participant has past or intended use of over-the-counter or prescription medication including herbal medications within 2 weeks or 5 half-lives prior to dosing * participant has used hepatic enzyme-inducing drugs within 2 months prior to dosing * participant has alanine transaminase (alt), aspartate aminotransferase (ast), or alkaline phosphatase (alp) \>1.0x upper limit of normal (uln) * participant has current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones) * participant has any clinically relevant electrocardiogram (ecg) finding at the screening visit or at baseline * participant has the presence of hepatitis b surface antigen (hbsag) at screening or within 3 months prior to dosing * participant has a positive hepatitis c antibody test result at screening or within 3 months prior to starting study intervention * participant has a positive human immunodeficiency virus (hiv) antibody test

Keywords: ethanol cannabidiol padsevonil